Label: DR SABHARWALS- lidocaine gel patch patch

  • NDC Code(s): 71318-111-15
  • Packager: Dr. Sabharwal's Wound Care
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated March 26, 2023

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Lidocaine 4%

  • INDICATIONS & USAGE

    temporarily relieves minor pain

  • PURPOSE

    Topical anesthetic

  • WARNINGS

    For external use only

  • DO NOT USE

    • More than one patch on your body at a time
    • On cut, irritated swollen skin
    • On puncture wounds
    • For more than one week without consulting a doctor
    • At the same time as other topical analgesics
  • WHEN USING

    • Use only as directed.
    • Read and follow all directions and warnings on this label.
    • Rare case of serious burns have been reported with products of this type.
    • Do not apply to wounds or damaged, broken or irritated skin.
    • Do not allow contact with the eyes and mucous membranes.
    • Do not bandage tightly or apply local heat (such as heating pads) to the area of use.
    • Do not use at the same time as other topical analgesic.
    • Dispose of used patch in manner that always keeps product away from children and pets.
    • Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.
    • A transient burning sensation may occur uopn application but generally disappears in several days.
    • If a severe burning sensation occurs, discontinue use immediately.
    • Discontinue use at least 1 hour before a bath or shower.
    • Do not use immediately after a bath or shower.
  • Stop use and ask a doctor if

    • Condition worsens
    • Redness is present.
    • Irritation develops.
    • Symptoms persist for more than 7 days or clear up and occur again within a few days.
    • You experience signs of skin injury, such as pain, swelling or blistering where the product was applied.
  • PREGNANCY OR BREAST FEEDING

    • ask a health professional before use.
  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a Poison Control Center right away.

  • INSTRUCTIONS FOR USE

    Adult and children over 12 years

    • Clean and dry affected area.
    • Remove backing from patch by firmly grasping both ends and gently pulling until back separates in middle.
    • Carefully remove smaller portion of backing from the patch and apply exposed portion of patch to affected area.
    • Use 1 patch for up to 12 hours.

    Children 12 years or younger:

    • ask a doctor
  • STORAGE AND HANDLING

    Store at room temperature 20-25 0C (68-77 0F)

  • INACTIVE INGREDIENT

    Alpha Tocopherol Acetate, Aluminium Glycinate, Aluminium Hydroxide, Aluminium Sulphate, Borax, Carbomer, Collodial Silicon
    Dioxide, DMDM Hydantoin, Glycerine, Kaolin, Polyacrylic Acid, Polyvinyl Alcohol, Polyvinylpyrrolidone, Propylene Glycol, Purified Water, Sodium Carboxymethyl Cellulose, Sodium Ethylenediaminetetraacetic Acid, Sodium Polyacrylate, Sorbitol, Sorbitan Monooleate, Tartaric Acid & Titanium Dioxide.

  • QUESTIONS

    Call +91-905-677-0088

  • DOSAGE & ADMINISTRATION

    Topical Patch for External Use Only

  • PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    DR SABHARWALS 
    lidocaine gel patch patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71318-111
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE84 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    KAOLIN (UNII: 24H4NWX5CO)  
    POLYVINYL ALCOHOL (100000 MW) (UNII: 949E52Z6MY)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    Product Characteristics
    ColorwhiteScore    
    ShapeRECTANGLESize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71318-111-1515 in 1 CARTON03/27/2023
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/27/2023
    Labeler - Dr. Sabharwal's Wound Care (862184668)
    Registrant - Dr Sabharwals Wound Care (862184668)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dr. Sabharwal's Wound Care862184668manufacture(71318-111)